Duns Number:331791694
Device Description: The NovaPort® one cannulas are thin-walled, wire-reinforced PUR femoral cannulas with a co The NovaPort® one cannulas are thin-walled, wire-reinforced PUR femoral cannulas with a cone without wire reinforcement where the cannulas can be clamped. The NovaPort® one cannulas are inserted percutaneously (Seldinger technique) into vessels. All necessary accessories are delivered with the product.
Catalog Number
8800079
Brand Name
NovaPort cannula
Version/Model Number
NovaPort® one Vascular Access and Introducer Kit
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2018
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DWF
Product Code Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Public Device Record Key
ea9589f3-c568-49d2-9b3f-c29d4e0a330b
Public Version Date
December 17, 2020
Public Version Number
4
DI Record Publish Date
September 30, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |